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Imagine being involved with cutting edge automation and innovative projects that change the course of our industry daily! At Labcorp, one of the world’s largest and most comprehensive pharmaceutical solutions service companies, you will have an opportunity to build an exciting career while you make a direct impact on the lives of millions.We have an excellent career opportunity for a Study Director I or II to join our growing Discovery Invitro Screening Metabolism team in Madison, WI.Embrace possibilities and change lives while growing your career.Position SummaryThe Study Director is an individual contributor who is responsible for managing the design, conduct and reporting of studies to meet scientific, regulatory and client requirements. They are the single point of study control and has overall responsibility for the scientific, technical, and regulatory conduct of studies as well as for the interpretation, documentation, and reporting of results. They have close and regular liaison with the client which is of primary importance. They will demonstrate competence in directing standard study types. All the studies undertaken will be non-GLP studies.Candidates given best consideration will have the following qualifications:
Knowledge of the drug development and high throughput screening processes, regulatory requirements and the scientific techniques of discovery metabolism studies required.
Drug metabolism and pharmacometrics knowledge is preferred.
Previous data interpretation and report writing experience.
Strong client relationship building and management skills.
Excellent organizational and time management skills
Good verbal and written communication skills
Ability to help foster a high professional standard and encourage positive staff relationships.
Education/Experience
PhD preferred, or MSc/BSc degree in an appropriate scientific discipline with some research experience in a relevant field.
Essential Duties:
Ensures that studies are performed to the required scientific, regulatory and client standards, in accordance with the study protocol and Labcorp standard operating procedures.
Uses knowledge of relevant assays and general expertise in the drug development process to offer guidance and suggestions on study design to meet client’s requirements, and plans accordingly (timelines, critical deadlines, etc.).
Prepares and completes study documents in partnership with study coordinators to meet client and regulatory requirements (outlines, protocols, reports, etc.). Ensures final report is compliant with SOPs and regulatory guidelines.
Manages projects and client interactions. Provides clients with regular progress updates and ensures expectations are met.
Effectively communicates study design, project requirements, and performance expectations to the study team. Maintains regular and timely communication within study team including start-up, ongoing, and close-out meetings. Ensures that all study communication is documented and maintained.
Monitors/reviews study progress at all times and anticipates problems that may affect timing, quality. Considers & discusses appropriate actions to resolve such problems. Issues directives and follows up to ensure compliance to requirements.
Manages study changes and ensures all additional costs are captured. Applies company procedures for financial, resource and contracting requirements.
Consistently meets on time delivery targets (protocols, results, reports).
Monitors andreviews client satisfaction to provide feedback to team and ensure repeat business.
Demonstrates basic knowledge of relevant assays and developing knowledge in the drug development process. Understands current technical applications in field, and familiar with the use of standard laboratory equipment and analytical instrumentation.
Demonstrates proficient level of scientific knowledge in chosen field. Shares scientific knowledge through internal and external meeting presentations.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here (https://careers.labcorp.com/global/en/us-rewards-and-wellness) .Why People choose to work at Labcorp:At Labcorp, it is our people that make us great – it is what our clients, our partners and, most importantly, what our employees say. Here, you will have the opportunity to collaborate with extraordinary people with diverse viewpoints. You will discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends.Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.We encourage all to applyIf you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site (https://careers.labcorp.com/global/en/accessibility) or contact us at Labcorp Accessibility (Disabilityapply@LabCorp.com) .For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/about/web-privacy-policy) .
